Rezatapopt Clinical Development - PMV Pharma's lead candidate, rezatapopt (PC14586), is a first-in-class p53 Y220C reactivator targeting the previously undruggable p53 Y220C mutation, found in approximately 1% of solid tumors[4,9] - Rezatapopt has shown clinical proof of concept with favorable safety and preliminary efficacy across multiple tumor types[4] - A single-arm, registrational, tumor-agnostic Phase 2 trial was initiated in Q1 2024, with an interim analysis planned for mid-2025 and NDA submission planned for the end of 2026[4] - In the Phase 1 study, tumor shrinkage was observed in 87% of patients with measurable disease at baseline, KRAS wild type, and at least one post-baseline assessment in the efficacious dose range[22] - Confirmed responses at the Recommended Phase 2 Dose (RP2D) of 2000 mg QD showed an Overall Response Rate (ORR) of 38% in TP53 Y220C/KRAS WT patients[24] - The median time to response in the efficacious dose range for TP53 Y220C/KRAS WT patients was 15 months[27] Safety and Tolerability - Rezatapopt demonstrated a favorable safety profile, with most Treatment-Related Adverse Events (TRAEs) being Grade 1 or 2[29] - The most frequent TRAEs were nausea (507%) and vomiting (433%), which improved when rezatapopt was given with food[29] - The rate of drug discontinuation due to a TRAE was low at 3%[29] Financial Position and Future Plans - PMV Pharma had $198 million in cash as of September 30, 2024, providing a cash runway to year-end 2026[4] - The Phase 2 trial includes defined registration paths in ovarian and tumor-agnostic patient populations, with approximately 90% of TP53 Y220C patients being KRAS wild type[39,42]

PMV Pharmaceuticals (PMVP) 2025 Conference June 05, 2025 03:45 PM ET Speaker0 Hello, everyone. Thank you so much for joining us at the Jefferies Global Healthcare Conference twenty twenty five. We're kind of winding the day down now, but it's my distinct honor and pleasure to be hosting PMV Pharma. We're gonna get a perspective today from the chief development officer, Deepika Jolotta. Deepika, welcome. Speaker1 Thank you so much. It's a pleasure to be here. Speaker0 So maybe we could just get directly into ...

Summary of PMV Pharmaceuticals (PMVP) FY Conference Call Company Overview - **Company**: PMV Pharmaceuticals (PMVP) - **Event**: FY Conference Call on May 27, 2025 Key Points Industry and Company Focus - PMV Pharmaceuticals is focused on oncology, specifically targeting p53 mutations in various solid tumors, including ovarian, lung, breast, and endometrial cancers [4][50]. Clinical Trial Updates - The pivotal Phase 2 trial involves 14 patients with p53 mutations and KRAS wild type across five cohorts: ovarian, lung, breast, endometrial, and others [4]. - As of March, approximately 90% of the targeted 60 sites for patient enrollment were open, with plans to complete enrollment by the end of 2025 [5][6]. - The company expects to enroll 50 patients for an interim analysis, with approximately 40% of these being ovarian cancer patients [10][12]. - The trial is designed to provide data on overall response rates (ORR) and durability of response (DOR) across different cohorts [41][43]. Data and Efficacy Expectations - Previous Phase 1 data indicated a median DOR of seven months across various histologies [14][18]. - The company anticipates that the first responses will be observable at the first or second scan, approximately six to twelve weeks into the trial [20]. - The target ORR for the study is set at 30%, which is considered clinically meaningful for ovarian cancer [58][62]. Regulatory and Commercialization Strategy - PMV Pharmaceuticals is considering filing for regulatory approval (NDA) by the end of 2026, likely focusing on ovarian cancer first due to the higher frequency of p53 mutations in this cohort [52][53]. - The company is engaging with the FDA and has had positive interactions, with no significant changes in the review team noted [74][76]. - There is an ongoing evaluation of commercialization strategies, including potential partnerships, especially for markets outside the US [71][72]. Financial Position - PMV Pharmaceuticals reported a cash position of $166 million, which is expected to sustain operations through 2026, covering the NDA submission process [73]. Additional Insights - The company is actively monitoring patient identification and tolerability issues, noting that p53 mutations are present in all next-generation sequencing (NGS) panels, which aids in patient identification [65]. - PMV Pharmaceuticals is also exploring combination therapies, such as with azacitidine for AML and MDS, with initial patient enrollment underway [81][84]. Future Expectations - An update on the trial data is expected in mid-2025, likely between July and August [8][10]. - The company aims to provide a comprehensive breakdown of data by cohort during the interim analysis [42][43]. This summary encapsulates the critical aspects of PMV Pharmaceuticals' current status, focusing on their clinical trials, regulatory strategies, financial health, and future expectations in the oncology sector.

UNITED STATES SECURITIES AND EXCHANGE COMMISSION FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-39539 PMV PHARMACEUTICALS, INC. (Exact Name of Registrant as Specified in its Charter) WASHINGTON, DC 20549 Delaware 46-3218129 (State or other jurisd ...

Financial Performance - PMV Pharmaceuticals ended Q1 2025 with $165.8 million in cash, cash equivalents, and marketable securities, down from $183.3 million as of December 31, 2024[5]. - Net loss for Q1 2025 was $17.5 million, compared to a net loss of $15.3 million for Q1 2024, representing an increase of approximately 14.3%[7]. - PMV Pharma's total assets decreased to $170.6 million as of March 31, 2025, from $191.3 million as of December 31, 2024[13]. - The company reported a net loss per share of $0.34 for Q1 2025, compared to $0.30 for Q1 2024[14]. Expenses - Research and development (R&D) expenses increased to $17.4 million in Q1 2025 from $13.2 million in Q1 2024, reflecting a rise of approximately 32.4%[7]. - General and administrative (G&A) expenses decreased to $4.1 million in Q1 2025 from $5.0 million in Q1 2024, a reduction of approximately 18%[7]. - Total operating expenses for Q1 2025 were $21.6 million, compared to $18.2 million in Q1 2024, marking an increase of approximately 18.5%[14]. Future Plans and Developments - The company plans to provide interim analysis data from the Phase 2 PYNNACLE trial in mid-2025, involving approximately 50 patients, with around 40% in the ovarian cancer cohort[3]. - PMV Pharma's cash runway is expected to extend to the end of 2026 based on current cash reserves[6]. - The FDA granted Fast Track designation to rezatapopt for treating patients with locally advanced or metastatic solid tumors with a p53 Y220C mutation[8].

Enrollment on track in Phase 2 pivotal portion of PYNNACLE clinical trial evaluating rezatapopt as monotherapy in patients with TP53 Y220C and KRAS wild-type advanced solid tumorsInterim analysis from Phase 2 PYNNACLE trial expected mid-2025; PMV plans to provide interim analysis data for approximately 50 patients with at least 18 weeks of follow-upCash, cash equivalents, and marketable securities of $165.8 million as of March 31, 2025, providing expected cash runway to end of 2026 PRINCETON, N.J., May 09, ...

Core Viewpoint - PMV Pharmaceuticals, Inc. (PMVP) has experienced a decline of 9.8% in its stock price over the past week, but the formation of a hammer chart pattern suggests a potential trend reversal as buying interest may be emerging to counteract selling pressure [1][2]. Technical Analysis - The hammer chart pattern indicates a possible bottoming out of the stock, with reduced selling pressure and a potential shift in control from bears to bulls [2][4]. - A hammer pattern is characterized by a small candle body and a long lower wick, signaling that despite a downtrend, buying interest has emerged to push the stock price up towards its opening price [3][4]. Fundamental Analysis - There has been a positive trend in earnings estimate revisions for PMVP, with a 1.2% increase in the consensus EPS estimate over the last 30 days, indicating analysts' confidence in the company's ability to report better earnings [6][7]. - PMVP holds a Zacks Rank of 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks, which historically correlates with outperformance in the market [8].

Financial Performance - The net losses for the years ended December 31, 2024, 2023, and 2022 were $58.7 million, $69.0 million, and $73.3 million, respectively, with an accumulated deficit of $368.7 million as of December 31, 2024[445]. - The total operating expenses for the year ended December 31, 2024, were $85.4 million, compared to $80.1 million in 2023, an increase of $5.3 million[460]. - The accumulated deficit reached $368.7 million as of December 31, 2024, reflecting significant operating losses since inception[467]. - Cash used in operating activities for the year ended December 31, 2024, was $51.3 million, a decrease from $55.7 million in 2023[480]. - The company has not generated any revenue from product sales and does not expect to do so in the foreseeable future[451]. Research and Development - Research and development expenses increased to $58.5 million for the year ended December 31, 2024, compared to $55.9 million in 2023, reflecting a rise of $2.6 million[461]. - The company initiated a Phase 1/2 clinical trial, PYNNACLE, for its lead product candidate, rezatapopt, in October 2020, and expects to provide interim data on the Phase 2 portion by mid-2025[445]. - As of October 2023, over 90% of sites globally for the PYNNACLE trial have been activated across the U.S., U.K., Europe, and Asia-Pacific[445]. Expenses and Restructuring - General and administrative expenses rose to $26.9 million for the year ended December 31, 2024, up from $24.2 million in 2023, an increase of $2.7 million[462]. - A restructuring plan was announced in January 2024, resulting in a workforce reduction of approximately 30% and non-recurring charges of $0.6 million[446]. - The company announced a restructuring plan in January 2024, reducing its workforce by approximately 30%[473]. - The company incurred costs of $0.6 million related to the restructuring plan during the fiscal year ending December 31, 2024[473]. Financial Position - As of December 31, 2024, the company had total financial assets of $183.3 million, a decrease of 19.8% from $228.6 million in 2023[465]. - The company expects its cash, cash equivalents, and marketable securities to be sufficient to fund operations at least through the end of 2026[475]. - The company filed a shelf registration statement for the offering of up to $200 million in various equity and debt securities[468]. Cash Flow - Cash used in investing activities in 2023 was $50.5 million, primarily due to purchases of marketable securities totaling $220.5 million[483]. - The company reported cash provided by investing activities of $53.4 million in 2024, primarily from maturities of marketable securities totaling $202 million[482]. - The company entered into a Lease Termination Agreement in August 2024, resulting in a termination fee of approximately $1.42 million[471]. Interest Income - Interest income, net decreased to $10.7 million for the year ended December 31, 2024, from $11.2 million in 2023, a decline of $0.5 million due to lower interest rates[463]. Accounting and Compliance - Recent accounting pronouncements are detailed in Note 2 of the audited consolidated financial statements for the year ended December 31, 2024[492].

Financial Performance - PMV Pharmaceuticals reported a net loss of $58.7 million for the year ended December 31, 2024, compared to a net loss of $69.0 million for the year ended December 31, 2023, representing a 15.8% improvement[12]. - Total operating expenses for the year ended December 31, 2024, were $85.4 million, compared to $80.1 million in 2023, reflecting an increase of 6.5%[12]. - Cash, cash equivalents, and marketable securities totaled $183.3 million as of December 31, 2024, down from $228.6 million at the end of 2023, providing a cash runway expected to last until the end of 2026[6]. Research and Development - Research and development expenses increased to $58.5 million in 2024 from $55.9 million in 2023, primarily due to clinical expenses for advancing the lead drug candidate, rezatapopt[12]. - The Phase 1 data of rezatapopt in advanced ovarian cancer patients showed a confirmed partial response rate of 46.7%, with a median duration of response of seven months[7]. - The company announced a collaboration with MD Anderson Cancer Center and Memorial Sloan Kettering Cancer Center for a Phase 1b study in approximately 25 patients with relapsed or refractory acute myeloid leukemia harboring a TP53 Y220C mutation[7]. - The company anticipates submitting a New Drug Application for rezatapopt by the end of 2026[4]. Clinical Trials - Enrollment in the Phase 2 monotherapy portion of the PYNNACLE trial is on track, with over 90% of sites activated across the U.S., Europe, U.K., and Asia-Pacific, and interim analysis data expected in mid-2025[4]. - The primary endpoint of the PYNNACLE trial is the overall response rate per blinded independent central review, with a target enrollment of 114 patients across five cohorts[4]. - The company discontinued enrollment in the combination arm of the Phase 1b PYNNACLE trial due to a lack of clinically meaningful benefit observed in patients[12].

Core Viewpoint - PMV Pharmaceuticals, Inc. reported strong progress in its clinical trials and financial results for the year ended December 31, 2024, highlighting the advancement of its lead drug candidate, rezatapopt, in treating cancers with TP53 mutations [1][4]. Clinical Development - The pivotal Phase 2 portion of the PYNNACLE trial is advancing well, with enrollment on track and more than 90% of sites activated across multiple regions [3][5]. - An interim analysis of the Phase 2 monotherapy data is expected in mid-2025, with a New Drug Application submission anticipated by the end of 2026 [3][5]. - Enrollment has begun in a Phase 1b study at MD Anderson Cancer Center, evaluating rezatapopt in patients with relapsed/refractory acute myeloid leukemia or myelodysplastic syndrome with a TP53 Y220C mutation [2][6]. Financial Performance - As of December 31, 2024, the company reported cash, cash equivalents, and marketable securities totaling $183.3 million, providing a cash runway expected to last until the end of 2026 [5][12]. - The net loss for the year ended December 31, 2024, was $58.7 million, a decrease from a net loss of $69.0 million in 2023 [12][17]. - Research and development expenses increased to $58.5 million in 2024 from $55.9 million in 2023, primarily due to clinical expenses related to rezatapopt [12][17]. Research Highlights - The Phase 1 data of rezatapopt in advanced ovarian cancer showed a confirmed partial response in 7 out of 15 patients, with a median duration of response of seven months [6]. - In advanced breast cancer, 3 out of 8 patients achieved a confirmed partial response, indicating a favorable safety profile [6]. - A paper detailing the discovery of rezatapopt was published, emphasizing its role as a first-in-class small-molecule reactivator of the p53 Y220C mutant [6][9].